BD MICROLANCE NEEDLES
Report
- Report Number
- 3002682307-2024-00232
- Event Type
- Malfunction
- Date Received
- October 31, 2024
- Date of Event
- October 11, 2024
- Report Date
- March 31, 2025
- Manufacturer
- BECTON DICKINSON, S.A.
- Product Code
- FMI
- UDI-DI
- 00382903032624
- PMA / PMN Number
- UNK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.
A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303262 AND LOT NUMBER 240408. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, THREE (3) B-BRAUN SYRINGES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. NO BD MICROLANCE NEEDLES WERE RETURNED FOR EVALUATION. THE SYRINGES WERE EXAMINED PRIOR TO THE DECONTAMINATION PROCESS AND SOME WHITE PARTICLES WERE OBSERVED WITHIN THE SYRINGES. IT IS POSSIBLE THAT CORING EFFECT TOOK PLACE. WE WOULD LIKE TO INFORM YOU THAT MATERIAL 303262 WAS CREATED WITH A REGULAR CANNULA BEVEL IN CONTRAST TO MATERIAL 304622 WHICH HAD A SHORT BEVEL. THIS MEANS THAT THE WAY THE NEEDLE PUNCTURES THE VIAL MUST CHANGE. FOR MATERIAL 303626 (REGULAR BEVEL), THE ANGLE OF PENETRATION OF THE VIAL SHOULD BE FROM 45 TO 60 DEGREES (IN CONTRAST TO THE 90-DEGREE PENETRATION FOR THE SHORT BEVELS). REGARDING THE QUESTION ¿WE WERE TOLD THAT YOU CHANGED THE BEVEL ON THESE CANNULAS IN 2022, IS THAT CORRECT?¿ THE MATERIAL CHANGE WAS A PART OF A PROJECT IMPLEMENTED IN 2021. THE PROJECT MADE MATERIAL 304622 OBSOLETE AND IMPLEMENTED MATERIAL 303262, WHICH VARIED IN BEVEL TYPE. REGARDING THE SECOND QUESTION: ¿COULD YOU GIVE US THE BATCH NUMBERS OF THESE NEW CANNULAS AND/OR THE DATE THEY WERE SOLD?¿ AS EXPLAINED ABOVE, YOU CAN COMPARE HOW LONG YOU HAVE HAD THESE NEW CANNULAS WITH THE MATERIAL NUMBER, AS ALL MATERIAL 303262 HAS THE NEW BEVEL. BASED ON THE INVESTIGATION RESULTS, NO ISSUE RELATED TO THE NEEDLE PRODUCT COULD BE DETERMINED. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.
IT WAS REPORTED THAT BD MICROLANCE NEEDLE CORES THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: I'M CONTACTING YOU BECAUSE OF OUR PROBLEMS WITH THE PINK 18G MICROLANCE 40MM CANULA AND THE CORING BEING MANUFACTURED AT THE NEUCHÂTEL HOSPITAL. I BELIEVE THAT MR (B)(6) EXPLAINED OUR CURRENT PROBLEMS TO YOU. IN FACT, WE'VE HAD A SIGNIFICANT INCREASE IN CORE DRILLING RECENTLY AND WE'RE LOOKING FOR THE CAUSE, BOTH IN THE CANULAS AND IN THE MANUFACTURERS OF THE PRODUCTS USED AND THEIR RUBBERS. WE WERE TOLD THAT YOU CHANGED THE BEVEL ON THESE CANULAS IN (B)(6) 2022, IS THAT CORRECT? WE'VE FOUND AN OLD CANULA AND WE THINK THAT IT MIGHT HAVE AN EFFECT ON THE CORE DRILLING. I'D LIKE TO KNOW, COULD YOU GIVE US THE BATCH NUMBERS OF THESE NEW CANULAS AND/OR THE DATE THEY WERE SOLD? THAT WAY WE CAN COMPARE HOW LONG WE'VE HAD THESE NEW CANULAS AND WHEN OUR PROBLEMS AROSE.
NO ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1897165 | BD MICROLANCE NEEDLES | NEEDLES, HYPODERMIC | FMI | BECTON DICKINSON, S.A. | 240408 | 00382903032624 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |